EMA consults on need for child medicines
Lists will help identify areas where further research is required
The European Medicines Agency (EMA) is assessing research and development needs in children’s medicines and has just started its first public consultation on an inventory of paediatric medications.
The list being developed by EMA’s Paediatric Committee will zone in on areas where further r&d is required.
According to the agency, this will enable companies to identify opportunities for business development, while the Paediatric Committee will be able to judge the need for medicines and studies when assessing draft paediatric investigation plans, wavers and deferrals. Furthermore, healthcare professionals and patients will have an information source to support decisions on which medicines to choose.
The first part of the inventory, released in late August, includes all cardiovascular medicines for use in children, with data needed on products such as dobutamine, clonidine, bisoprolol and nitric oxide.
EMA will be releasing similar lists for other therapeutic areas for public consultation during 2012 and 2013.
